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Effectiveness and Safety of YVOIRE Y-Solution 540

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04855188
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
LG Chem

Study Description
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Brief Summary:
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection

Condition or disease Intervention/treatment Phase
Wrinkles in the Nasolabial Folds Device: YVOIRE Y-Solution 540 Device: YVOIRE volume plus Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 Versus YVOIRE Volume Plus in Nasolabial Folds Injection
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: YVOIRE Y-Solution 540 Device: YVOIRE Y-Solution 540
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
Active Comparator: YVOIRE volume plus Device: YVOIRE volume plus
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.


Outcome Measures
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Primary Outcome Measures :
  1. WSRS responder rate [ Time Frame: 24 weeks after the last injection ]
    the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 3 (moderate) or 4 (severe) on the 5-graded WSRS
  • who sign the written informed consent form

Exclusion Criteria:

  • who have received permanent facial implants
  • who have received semi-permanent fillers
  • who have undergone temporary dermal filler treatment within 12 months
  • who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
  • who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855188


Contacts
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Contact: Jong Hee Jin 82-2-6987-4151 jjonghee@lgchem.com
Contact: Jiyoon Lee lgclinical@lgchem.com

Locations
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China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China
Sponsors and Collaborators
LG Chem
More Information
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT04855188    
Other Study ID Numbers: LG-HACL027
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No